Drug coated medical devices are typically stored and transported into packages that provide a sterile, bacteria free environment. The package must also be able to maintain the integrity of the drug coating for an effective dosage, usually for a shelf life of one year. Accordingly, certain drug coatings require regulated conditions for efficacy, including moisture, as well as ventilation, light exposure, and oxygen.
Such package typically includes a thermoformed tray containing a drug coated medical device, which is enclosed and sealed within an outer foil pouch. The thermoformed tray may have a TYVEK® material lid to allow the medical devices to be sterilized before being enclosed within the outer foil pouch. Alternatively, the thermoformed tray, without a TYVEK® material lid, is inserted within the outer foil pouch that includes a TYVEK® strip to allow the medical devices to be sterilized after being enclosed within the outer foil pouch. However, the outer foil pouch prevents the end user from viewing the medical device contained therein. In addition, as the packages become larger due to the size of the medical devices, the outer foil package also becomes larger, e.g., 24 inches wide. Such larger foil packages are more susceptible to being compromised, thereby resulting in the possibility of unacceptable levels of bacteria, moisture, ventilation, light exposure, and oxygen. One reason is the increased risk of incomplete sealing and channels, which are formed from folds of the pouches during the sealing process. Another reason is the increased risk of punctured openings in the outer foil package as a result of damage during shipping and handling of the package.
Thus, what is needed is a package specifically configured for drug coated medical devices, which can permit an end user to view the medical devices inside of the package without opening the package. In particular, what is needed is a package configured for moisture-sensitive devices, such as drug coated medical devices, to extend the shelf life of such devices, thereby reducing the costs of scrapping such packages with the medical devices and reducing the costs of environmental wastes.